An Overview of Tesamorelin

Tesamorelin, also known as TH9507, is a type of medicine called a growth hormone-releasing factor (GHRF). GHRF causes growth hormone to be created and spread in the body, which helps control metabolism, body shape, and use of energy.

Indications and Usage

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Tesamorelin was approved by the U.S. Food and Drug Administration (FDA) on November 10, 2010 for the treatment of lipodystrophy in HIV-infected individuals. Lipodystrophy is a condition that causes changes in placement of body fat, including wasting and fat accumulation, and changes in metabolism. Individuals with lipodystrophy may develop excess fat most notably around the liver, stomach, and other abdominal organs (visceral body fat).

Dosage Form/Administration

Always take this medicine as your doctor instructs.

Dosage Forms and Strengths

Tesamorelin is given as a daily shot (injection).

What storage conditions are needed for this medicine?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know?

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Recommended Daily Dose

Tesamorelin has been studied in clinical trials as a once-daily 2-mg injection.

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take more than one dose of tesamorelin in 1 day and do not take a double dose to make up for a missed dose.

Contraindications

Before taking tesamorelin,

Tell your doctor and pharmacist if you are allergic to tesamorelin or any other medications.

Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you more carefully for side effects.

Tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking tesamorelin, call your doctor. Tell your doctor if you are breast-feeding. You should not breast-feed if you are infected with HIV or if you are taking tesamorelin.

Possible Side Effects

Tesamorelin may cause side effects.

The following life-threatening or serious side effects have been reported. Contact your doctor immediately if you experience:

Sensory loss

Pain

Muscle weakness or pain

Wasting of muscle in the hands, legs, or feet

Diarrhea with fever and dehydration

Loss of mobility

Congestive heart failure

Rash at the injection site

Joint pain

Swelling

Tesamorelin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the U.S. FDA's MedWatch Adverse Event Reporting program online at www.fda.gov/Safety/MedWatch or by phone at 1-800-332-1088.

Drug Interactions

Unless your doctor tells you otherwise, continue your normal diet.

Clinical Trials

Click here to search ClinicalTrials.gov for trials that use Tesamorelin.

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